FDA revokes approval of Avastin for breast cancer

Nov 19 2011

The New York Times: Avastin Loses Approval From F.D.A. to Treat Breast Cancer
The commissioner of the Food and Drug Administration on Friday revoked the approval of the drug Avastin as a treatment for breast cancer, ruling in an emotional issue that pitted the hopes of some desperate patients against the statistics of clinical trials. The commissioner, Dr. Margaret A. Hamburg, said that the drug was not helping breast cancer patients to live longer or control their tumors, but did expose them to potentially serious side effects such as severe high blood pressure and hemorrhaging (Pollack, 11/18).

NPR: FDA Pulls Approval Of Avastin For Breast Cancer
After more than a year of deliberations and an unprecedented public hearing in June, the agency has revoked approval of the biotech blockbuster Avastin, a medicine that chokes off the blood supply to various cancer cells, as a treatment for metastatic breast cancer (Hensley, 11/18).

Bloomberg: Roche's Avastin Revoked For Use In Breast Cancer, FDA Says
Avastin, with $6.2 billion in 2010 sales, didn't extend patients' lives and triggered serious side effects including high blood pressure and bleeding when used to attack the disease, said Commissioner Margaret Hamburg of the Food and Drug Administration in a statement today. The drug remains approved for colon, lung, kidney and brain cancer (Edney, 11/18).

The Wall Street Journal: FDA Revokes Avastin Approval As Breast Cancer Treatment .
Because the drug is already on the market for other cancers, however, doctors could still use the product as a breast cancer treatment but Roche won't be allowed to market it for that use in the U.S. Avastin was approved for metastatic breast cancer, or cancer that spread beyond the breast in February 2008 for use in combination with a chemotherapy drug, under the FDA's accelerated approval program. That program is a type of temporary approval to allow products that treat life-threatening conditions to be approved with less clinical data than typically required (Corbett Dooren, 11/18).

The Washington Post: FDA Revokes Avastin's Approval For Breast Cancer Treatment
The fate of the drug for breast cancer has been closely watched by patients, oncologists, women's health advocates, health-care policymakers, politicians and the pharmaceutical industry. The case has triggered strong reactions from advocates of easier access to new treatments and from critics fearing health-care rationing. It is also being seen as one of the most visible medical examples of scientific evidence winning out over an animated public outcry. Ultimately, clinical trials failed to support the drug's early promise for breast cancer treatment (Stein, 11/18).

The Associated Press: FDA Revokes Approval Of Avastin For Breast Cancer
So even though the FDA formally revoked Avastin's approval as a breast cancer treatment, women could still receive it -; but their insurers may not pay for it. ... However, "Medicare will continue to cover Avastin," said Brian Cook, spokesman for the Centers for Medicare & Medicaid Services. The agency "will monitor the issue and evaluate coverage options as a result of action by the FDA but has no immediate plans to change coverage policies" (Neergaard, 11/18).